510(k) Report

FDA applicant

Gynex Corp.

Concord, CA5 decisions1998–20060 recalls

FDA records 5 decisions for Gynex Corp. (Concord, CA) from 1998 to 2006: 5 510(k) clearances. Most are in product codes HEX (Colposcope (And Colpomicroscope)) and KNA (Instrument, Manual, Specialized…). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Gynex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gynex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gynex Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HEXColposcope (And Colpomicroscope)1decision
  • KNAInstrument, Manual, Specialized Obstetric-Gynecologic1decision
  • HDCTenaculum, Uterine1decision
  • HEESet, Anesthesia, Paracervical1decision
  • HGIElectrocautery, Gynecologic (And Accessories)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K980247Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett TenaculumGynex Corp. · 19981cites it

What has FDA decided for it lately?

  • K061306CO-1000 Colposcope, MultipleGynex Corp. · 2006
  • K982739Gynex ElectrodesGynex Corp. · 1999
  • K980238Gynex Extended Reach NeedleGynex Corp. · 1998
  • K980237Gynex EndospeculumGynex Corp. · 1998
  • K980247Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett TenaculumGynex Corp. · 1998

All 5 as Gynex Corp. →